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NCT06619301 · ClinicalTrials.gov registry record · Phase 3
RCT Glargine vs NPH for Treatment of DM in Pregnancy
A Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy, sponsored by Loyola University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06619301: Recruiting Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy, sponsored by Loyola University.
NCT06619301 is a Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy that is actively recruiting participants, run by Loyola University. The registered enrollment target is 160 participants, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06619301, a Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy, is actively recruiting participants, sponsored by Loyola University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.
Primary Outcome
Episodes of hypoglycemia with blood glucose less than 60 mg/dL
Conditions Studied
Interventions
- DRUG Insulin glargine
- DRUG insulin NPH
Study Locations (1)
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 3 |
What NCT06619301 shows while recruiting
NCT06619301 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Type 2 Diabetes Mellitus (T2DM) appearing as the primary indexed condition, and to 2 interventions - of which Insulin glargine is the first listed.
NCT06619301 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06619301 about?
NCT06619301 is a clinical study titled "RCT Glargine vs NPH for Treatment of DM in Pregnancy". We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, gla...
What is the current status of trial NCT06619301?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2024-04-01. Estimated completion is 2027-01-01.
What conditions does trial NCT06619301 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus (T2DM), Diabetes Mellitus in Pregnancy, Gestational Diabetes Mellitus, Class A2.
What interventions are being tested in trial NCT06619301?
The interventions under investigation include: Insulin glargine (DRUG), insulin NPH (DRUG).
Who is sponsoring clinical trial NCT06619301?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06619301 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus (T2DM)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06619301's enrollment target sits among peer trials
160 12th of 24 higher than 13 of 24 other Type 2 Diabetes Mellitus (T2DM) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus (T2DM) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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